Alzheimer’s Association Issues Its First Blood-Based Biomarker Guideline for Alzheimer’s Diagnosis

The Alzheimer’s Association has released its first clinical practice guideline with recommendations for the use of blood-based biomarker (BBM) tests in the diagnosis, treatment, and care of people with Alzheimer disease (AD). Presented at the 2025 meeting of the Alzheimer’s Association International Conference (AAIC) and published in Alzheimer’s & Dementia, the guideline is intended to help clinicians responsibly integrate BBM testing into practice and improve diagnostic accuracy and speed, ultimately facilitating earlier treatment decisions.

The guideline was developed by a multidisciplinary panel of 11 clinical neurologists, geriatricians, nurse practitioners, physician assistants, and other experts in the field. Following the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework, the panel performed a systematic review of 49 observational studies covering 31 BBM tests, while emphasizing a brand-agnostic, performance-based evaluation to ensure that recommendations were robust, unbiased, and ready for future updates as new evidence emerges.

Following their systematic review, the multidisciplinary panel developed 2 recommendations and 1 Good Practice Statement, which are quoted below from a press release issued by the Alzheimer’s Association:

1. Recommendation 1: “In patients with objective cognitive impairment presenting for specialized memory care, the panel suggests using a high-specificity BBM test as a triaging test in the diagnostic workup of Alzheimer’s disease.”
2. Recommendation 2:“In patients with objective cognitive impairment presenting for specialized memory care, the panel suggests using a high-sensitivity and high-specificity BBM test as a confirmatory test in the diagnostic workup of Alzheimer’s disease.”
3. Good Practice Statement:“A BBM test should not be obtained before a comprehensive clinical evaluation by a healthcare professional, and test results should always be interpreted within the clinical context. The panel urges clinicians to consider the pre-test probability of Alzheimer’s disease pathology for each patient when deciding whether or not to use a BBM test.”

“This is a pivotal moment in Alzheimer’s care,” said Maria C. Carrillo, PhD, Coauthor of the Clinical Practice Guideline and Chief Science Officer and Medical Affairs Lead of the Alzheimer’s Association. “For the first time, we have a rigorously evidence-based guideline that empowers clinicians to use blood biomarker tests confidently and consistently. Adoption of these recommendations will lead to quicker, more accessible, more accurate diagnoses—and better outcomes for individuals and families affected by Alzheimer’s.”

Earlier this year, the Alzheimer’s Association published recommendations for evaluating, diagnosing, and disclosing AD and related dementias in Alzheimer’s & Dementia.